Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

— ALPACA  

Official title:

Description of Lactulose Administration by Balloon Rectal Tube in Severe Hepatic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06248736
• Other study ID #: CHU Grenoble/ ALPACA
• Status: Recruiting
• Start date: June 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Grenoble
• Contact: Pr BOUZAT
• Phone: 0476766729
• Email: pbouzat[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute liver failure in cirrhotic patients is associated with a one-month mortality of 48%. Encephalopathy, largely related to hyperammonemia, is a frequent complication of liver failure and is a poor prognostic marker. Lactulose decreases ammonia by acidification of the colon, replacement of urease-producing bacteria and creation of a laxative effect. Thus, the administration of lactulose in patients with severe hepatic encephalopathy reduces mortality by more than 40%.

In intensive care patients, lactulose is often administered rectally. The use of simple rectal tubes is associated with frequent leakage of lactulose as well as faecal discharge and therefore risks of infection and skin lesions. Balloon rectal tubes with a drug delivery valve have recently been developed and used in this indication. The aim of this study is therefore to describe the use of these balloon rectal tubes to administer Lactulose in severe hepatic encephalopathy.

This suggests that ammonia reduction in these patients may prolong survival time.

No studies have described the administration of Lactulose via the rectal route with a balloon tube. The descriptive methodology is therefore appropriate. This is a preliminary study allowing data collection to establish the methodology for a subsequent clinical trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• Patients treated with Lactulose with balloon rectal probe

Exclusion Criteria:

• Patient(s) objecting to the use of their data for research purposes

• Rectal probe contraindication: damage to the rectal mucosa, rectal surgery, severe haemorrhoids, rectal stenosis, rectal tumour,

• Lactulose contraindication (person unable to absorb galactose)

• Patients deprived of liberty, under guardianship or curators

• Pregnant women

• Patient not affiliated to a social security scheme

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Locations

Country	Name	City	State
France	Pr PIERRE BOUZAT	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (7)

Bernal W, Hall C, Karvellas CJ, Auzinger G, Sizer E, Wendon J. Arterial ammonia and clinical risk factors for encephalopathy and intracranial hypertension in acute liver failure. Hepatology. 2007 Dec;46(6):1844-52. doi: 10.1002/hep.21838. — View Citation

Bhatia V, Singh R, Acharya SK. Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. 2006 Jan;55(1):98-104. doi: 10.1136/gut.2004.061754. Epub 2005 Jul 15. — View Citation

Clemmesen JO, Larsen FS, Kondrup J, Hansen BA, Ott P. Cerebral herniation in patients with acute liver failure is correlated with arterial ammonia concentration. Hepatology. 1999 Mar;29(3):648-53. doi: 10.1002/hep.510290309. — View Citation

Dasarathy S, Mookerjee RP, Rackayova V, Rangroo Thrane V, Vairappan B, Ott P, Rose CF. Ammonia toxicity: from head to toe? Metab Brain Dis. 2017 Apr;32(2):529-538. doi: 10.1007/s11011-016-9938-3. Epub 2016 Dec 24. — View Citation

Jalan R, De Chiara F, Balasubramaniyan V, Andreola F, Khetan V, Malago M, Pinzani M, Mookerjee RP, Rombouts K. Ammonia produces pathological changes in human hepatic stellate cells and is a target for therapy of portal hypertension. J Hepatol. 2016 Apr;64 — View Citation

Ravi S, Bade KS, Hasanin M, Singal AK. Ammonia level at admission predicts in-hospital mortality for patients with alcoholic hepatitis. Gastroenterol Rep (Oxf). 2017 Aug;5(3):232-236. doi: 10.1093/gastro/gow010. Epub 2016 May 1. — View Citation

Shalimar, Sheikh MF, Mookerjee RP, Agarwal B, Acharya SK, Jalan R. Prognostic Role of Ammonia in Patients With Cirrhosis. Hepatology. 2019 Sep;70(3):982-994. doi: 10.1002/hep.30534. Epub 2019 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe ammonia during lactulose administration by balloon rectal tube	Variation of ammonia before treatment and after 48h of treatment, during 1 week in µmol/l	48 hours during 1 week
Secondary	Describe the neurological course following administration of lactulose via a balloon rectal tube	Score Richmond Agitation-Sedation Scale from the minimum value -4 to maximum value + 4 Richmond Agitation and sedation scale , agitation	at 7 days
Secondary	Describe the retention of the balloon rectal tube	Frequency of leakage during and within 1 hour of lactulose administration when the rectal tube balloon is inflated,	at 7 days
Secondary	Describe the skin tolerance of patients during hospitalization.	Percentage of patients with at least one pressure sore or infection in the lumbar, pelvic, buttocks, or buttock area	at 28 days
Secondary	Describe complications related to the balloon rectal tube	Percentage of patients with at least one of the following complications: leakage of faeces during or after use of the catheter; rectal bleeding; peri-anal skin damage (fissure, ulcer, infection); bowel obstruction; bowel perforation, rectal pain, abdominal distension.	at 28 days
Secondary	Describe complications related to rectal lactulose administration	Percentage of patients with at least one of the following complications: hypernatremia > 150 mmol/L, dehydration, renal insufficiency urea creatinemia.	at 28 days
Secondary	Patient outcomes	Duration of invasive ventilation, duration of resuscitation or intensive care, duration of hospital stay, mortality	at 28 days
Secondary	Caregiver satisfaction	Anonymised use and maintenance satisfaction questionnaire into 0 is the worst score and 10 is the better score	at 7 days